Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)
This study has been completed.
Sponsor:
Arpida AG
Information provided by:
Arpida AG
ClinicalTrials.gov Identifier:
NCT00303550
First received: March 15, 2006
Last updated: March 26, 2007
Last verified: March 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study is now completed
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Diseases, Bacterial |
Drug: Intravenous iclaprim Drug: Intravenous linezolid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections (ASSIST-2) |
Resource links provided by NLM:
Further study details as provided by Arpida AG:
Primary Outcome Measures:
- Clinical cure rate (the ratio of number of clinically cured patients to the total number of patients in the population) at 7 to 14 days after the end of therapy
Secondary Outcome Measures:
- Microbiological eradication rate at 7-14 days after end of therapy
- Safety evaluations conducted during the study
| Study Start Date: | March 2006 |
Primary Objective:
The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).
Secondary Objectives:
The secondary objectives of this study are to compare iclaprim with linezolid regarding:
- Clinical efficacy at the end of study medication treatment;
- Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (cSSSI);
- Clinical outcome in the microbiologically evaluable (ME) population;
- Bacteriologic outcome in the ME population;
- Bacteriologic eradication rates of Baseline (BL) pathogens;
- Clinical outcome in the modified intent-to-treat (MITT) population;
- Bacteriologic outcome in the MITT population;
- Baseline in vitro susceptibility of isolated pathogens in the ME population; and
- Safety and tolerability of iclaprim treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.
Exclusion Criteria:
- Known or suspected hypersensitivity to any study medication or other related anti-infective medication
- Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
- Previous enrollment in this study
- Treatment with any investigational drug within 30 days before enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303550
Locations
| United States, Illinois | |
| Edward Hospital & Health Services | |
| Naperville, Illinois, United States, 60540 | |
| United States, Wyoming | |
| Wyoming Medical Center | |
| Casper, Wyoming, United States, 82601 | |
Sponsors and Collaborators
Arpida AG
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00303550 History of Changes |
| Other Study ID Numbers: | Protocol No. ICLA-09-CSI2, ASSIST-2 |
| Study First Received: | March 15, 2006 |
| Last Updated: | March 26, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Arpida AG:
|
skin infection complicated skin infection skin structure infection Complicated Skin and Skin Structure Infection |
Additional relevant MeSH terms:
|
Skin Diseases Skin Diseases, Bacterial Bacterial Infections Skin Diseases, Infectious Infection Linezolid Iclaprim |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013